TEL AVIV, Israel, July 9,
2018 /PRNewswire/ -- Cellect Biotechnology Ltd.
(Nasdaq: APOP), a developer of a novel stem cell production
technology, announced that it has entered into a strategic
manufacturing and supply agreement with Swiss Biotech Center (SBC)
to secure production of FasL protein - Cellect's main active
ingredient in ApoGraft™ and the line of Apotainer™.
According to the agreement, SBC grants to Cellect exclusivity to
the FasL protein developed by SBC for a period of five years. The
agreement further provides for the production of clinical batches
of the FasL protein for Cellect's planned US clinical trials.
Cellect and SBC contemplate expanding production capacity to meet
future needs including marketing and collaborations with licensors
of Cellect technology.
The FasL protein is a key active ingredient in Cellect's product
line and technology for cell separation and functional selection of
stem cells. As Cellect advances in its product development, it
becomes essential to secure a consistent and reliable supply of
pharma-grade FasL. Production of large quantities of clinical grade
material is currently the gating item for initiating US based
clinical trials.
Dr. Shai Yarkoni, Cellect CEO
comments: "We are getting ready to support many clinical trials and
collaborations using the Apograft containing FasL. This agreement
supports Cellect's mission statement of enabling a multi-billion
global market over the next 5 years while positioning Cellect
towards potentially meeting commercial demand for millions of
patients worldwide in need of stem cell therapy, as well as
providing raw materials for stem cells research centers and the
biobanking industry."
About Swiss Biotech Center (SBC)
Swiss Biotech Center (SBC) offers services and a dedicated
environment for the development and manufacturing of innovative
drugs such as biologics or Advanced Therapy Medicinal Products
(ATMP) by gathering all the competences, internally or externally,
infrastructures and technologies. Positioned as a solutions
provider aiming at delivering high quality drugs for saving lifes,
SBC is highly oriented towards boosting value creation by
accelerating the path to clinical development.
About Regenerative Medicine and Cell Therapy
Regenerative medicine is a novel approach using cells and
tissues to replace or regenerate human cells, tissues or organs in
a wide variety of medical indications. This could be achieved by
either stimulating the body to use its own repair mechanisms to
heal tissues or organs, or by growing tissues and organs in the
laboratory and transplanting them into the patient.
Stem cells play a major role in the achievement of the
extraordinary potential results in regenerative medicine. In cell
therapies they can be injected to reconstitute the entire blood
system in bone marrow transplantations. Alternatively, their
injection can supply the necessary biologically active molecules to
induce the patients' own cells to regain normal function, as used
in immunomodulation therapy. In tissue engineering, where entire
organs like the retina, bone, cartilage or the skin may be
replaced, stem cells are the starting material for the growth of
such tissues in the laboratory. Moreover, in tissue engineering an
artificial system might be created by inducing cells to perform
certain biochemical functions lost due to disease (e.g., artificial
pancreas or liver).
Regenerative medicine using cellular therapy in combination with
new technologies like tissue engineering and gene transfer can be
used in a virtually unlimited number of indications. The most
frequently used cells are hematopoietic stem cells (HSC) due to
their capability to reproduce the entire blood system in blood
cancer and hematological disorders. Mesenchymal stem cells, which
have the capability to differentiate to a large number of tissue
types like bone, cartilage, fat, heart muscle and more, are of
growing importance. Potential applications of cell therapies
include treating cancers, autoimmune disease, urinary problems and
infectious disease, rebuilding damaged cartilage in joints,
repairing spinal cord injuries, improving a weakened immune system,
and helping patients with neurological disorders.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: APOP) has developed a
breakthrough technology for the selection of stem cells from any
given tissue that aims to improve a variety of stem cell-based
therapies.
The Company's technology is expected to provide research,
hospitals and pharma companies with the tools to rapidly isolate
stem cells in quantity and quality allowing stem cell-based
treatments and procedures in a wide variety of applications in
regenerative medicine. The Company's current clinical trial is
aimed at bone marrow transplantations in cancer treatment.
Forward Looking Statements
This press release contains forward-looking statements about the
Company's expectations, beliefs and intentions. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe", "expect", "intend", "plan", "may", "should",
"could", "might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. For
example, forward-looking statements are used in this press release
when we discuss Cellect's intent regarding future production
capacity. These forward-looking statements and their implications
are based on the current expectations of the management of the
Company only and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. In
addition, historical results or conclusions from scientific
research and clinical studies do not guarantee that future results
would suggest similar conclusions or that historical results
referred to herein would be interpreted similarly in light of
additional research or otherwise. The following factors, among
others, could cause actual results to differ materially from those
described in the forward-looking statements: the Company's history
of losses and needs for additional capital to fund its operations
and its inability to obtain additional capital on acceptable terms,
or at all; the Company's ability to continue as a going concern;
uncertainties of cash flows and inability to meet working capital
needs; the Company's ability to obtain regulatory approvals; the
Company's ability to obtain favorable pre-clinical and clinical
trial results; the Company's technology may not be validated and
its methods may not be accepted by the scientific community;
difficulties enrolling patients in the Company's clinical trials;
the ability to timely source adequate supply of FasL; risks
resulting from unforeseen side effects; the Company's ability to
establish and maintain strategic partnerships and other corporate
collaborations; the scope of protection the Company is able to
establish and maintain for intellectual property rights and its
ability to operate its business without infringing the intellectual
property rights of others; competitive companies, technologies and
the Company's industry; unforeseen scientific difficulties may
develop with the Company's technology; and the Company's ability to
retain or attract key employees whose knowledge is essential to the
development of its products. Any forward-looking statement in this
press release speaks only as of the date of this press release. The
Company undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual
Report on Form 20-F for the fiscal year ended December 31, 2017 filed with the U.S. Securities
and Exchange Commission, or SEC, which is available on the SEC's
website, www.sec.gov, and in the Company's periodic filings with
the SEC.
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+972-9-974-1444
Swiss Biotech Center
Massimo Nobile, CEO
Route de l'Ile-aux-Bois 1A
1870 Monthey (Switzerland)
+41(0)24-472-19-05
massimo.nobile@swissbiotechcenter.com
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SOURCE Cellect Biotechnology Ltd.